Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease

Small exploratory pilot study to assess effects of a transcutaneous vibro-acoustic therapy device (Apollo Neuro) in people with Parkinson's disease (PD).

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Transcutaneous vibro-acoustic device

Detailed Description

The overarching goal of this study is to investigate changes in anxiety, nighttime heart rate variability, and fear of falling in people with PD before and after 3-months usage of a transcutaneous vibro-acoustic therapy device. Positive findings in this small exploratory pilot trial may support future studies of transcutaneous vibro-acoustic therapy for individuals with PD.

This study was terminated due to lack of resources. One participant was consented, but no data was collected.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Domino's Farms

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with Parkinson's Disease (Hoehn and Yahr stage 2 or higher)
• Individuals on or off dopaminergic therapy
• Present of anxiety or panic disorder
• Fear of falling
• Understanding of use and care of smart phones and devices

Exclusion Criteria:

• Presence of significant dementia
• Disorders which may resemble PD, such as dementia with Lewy bodies, vascular dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism.
• Patients with a cardiac pacemaker
• History of brain surgery or placement of a deep brain stimulator
• Psoriasis vulgaris (or other inflammatory skin condition) on or near skin where the vibro-acoustic device and sleep tracking ring will be donned.
• Patients on beta-blockers, benzodiazepines, antipsychotics, and stimulants (except for the treatment of attention deficit disorder/ADHD).
• Pregnancy
• Patients who begin cognitive behavioral therapy or a selective serotonin reuptake inhibitor (SSRI) medication for an anxiety disorder or other psychiatric disorder after the baseline clinical assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parkinson's Disease; Participants will use the vibro-acoustic device 90-120 days for 6 hours at night on the Apollo Neuro setting "Sleep and Renew".	Device: Transcutaneous vibro-acoustic device; Wearable device which sends low-frequency sound vibrations through the skin.; Other Names: Apollo Neuro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Nighttime Heart Rate Variability	Average heart rate variability during the night, as measured by Oura ring device (measured in s).	after 90-120 days of intervention
Paced Auditory Serial Addition Test score	A measure of cognitive function that assesses auditory information processing speed and flexibility, scored as the total number correct out of 60. Higher scores indicate better performance.	after 90-120 days of intervention
Spielberger State-Trait Anxiety Inventory score	40-item questionnaire to assess anxiety. Scores range from 40-160 with higher scores indicating greater severity of anxiety.	after 90-120 days of intervention
Hamilton Anxiety Scale score	14-item questionnaire to evaluate severity of anxiety symptoms. Scores range from 0-56, with higher scores indicating greater severity of anxiety.	after 90-120 days of intervention
Hamilton Depression Scale score	17-item questionnaire to assess the severity of depression symptoms. Scores range from 0-61, with higher scores indicating more severe depression.	after 90-120 days of intervention
Beck Depression Inventory score	21-item scale to evaluate the severity of depression symptoms. Scores range from 0-63, with higher scores indicating more severe depression.	after 90-120 days of intervention
Beck Anxiety Inventory score	21-item questionnaire to assess the severity of anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.	after 90-120 days of intervention
Geriatric Depression Scale score	15-item questionnaire scored from 0-15, with greater scores indicating greater severity of depression.	after 90-120 days of intervention
Short Activities-specific Balance Confidence Scale score	16-item scale to assess confidence in balance while performing different tasks. Scores range from 0-100 with greater scores indicating greater confidence.	after 90-120 days of intervention
New Freezing of Gait Questionnaire score	9-item questionnaire evaluating the severity of freezing of gait. Scores range from 0-29, with higher scores indicating more severe freezing of gait.	after 90-120 days of intervention
Instrumental Activities of Daily Living Scale score	8-item questionnaire to assess functional independence. Scores range from 0-8, with higher scores indicating higher functioning.	after 90-120 days of intervention
Insomnia Severity Index score	7-item scale to assess severity of insomnia. Scores range from 0-28, with higher scores indicating greater severity of insomnia.	after 90-120 days of intervention
Epworth Sleepiness Scale score	8-item scale to assess daytime sleepiness. Scores range from 0-24, with higher scores indicating greater daytime sleepiness.	after 90-120 days of intervention
Fatigue severity Scale score	9-item scale to measure the severity of fatigue. Scores range from 9-63, with higher scores indicating greater severity of fatigue.	after 90-120 days of intervention
Perceived Stress Scale score	10-item questionnaire to evaluate perceived levels of stress. Scores range from 0-40, with greater scores indicating greater perceived stress.	after 90-120 days of intervention
Short Fall Efficacy Scale International score	7-item questionnaire to evaluate fear of falling. Scores range from 7-28 with greater scores indicating greater fear of falling.	after 90-120 days of intervention
Fatigue Visual Analogue Scale score (Alternate form)	Scored from 0-100, with higher score indicating greater fatigue.	after 90-120 days of intervention
Mayo Sleep Questionnaire Score on item 8	Item 8 on the Mayo Sleep Questionnaire asks the participant to rate their general level of alertness over the past 3 weeks on a scale from 0 to 10, with 0 indicating they sleep all day and 10 indicating they are fully and normally awake.	after 90-120 days of intervention

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Prabesh Kanel, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Actual): August 9, 2023
• Study Completion (Actual): August 9, 2023

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: anxiety; transcutaneous vibro-acoustic therapy
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: HUM00231771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No